Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05293678 | Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19 | PHASE1 | COMPLETED | 104 | — | — | Apr 12, 2022 | Jan 26, 2023 | Feb 23, 2023 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Lower IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Mid IV Dose 1 | EXPERIMENTAL | Randomized 3:1 |
| Mid IV Dose 2 | EXPERIMENTAL | Randomized 3:1 |
| Higher IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Lower SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Mid SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Higher SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Name | Type | Description |
|---|---|---|
| REGN15160 (IV) | DRUG | Administered in single intravenous (IV) dose |
| Matching Placebo (IV) | DRUG | Administered in single IV dose |
| REGN15160 (SC) | DRUG | Administered in single subcutaneous (SC) dose |
| Matching Placebo (SC) | DRUG | Administered in single SC dose |
Key Inclusion Criteria: 1. Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards 2. Has received c...